AB0428 SAFETY AND PERSISTENCE OF TREATMENT WITH GOLIMUMAB VERSUS CERTOLIZUMAB IN RHEUMATOID ARTHRITIS: RESULTS FROM BIOBADABRASIL COHORT STUDY.
Authors: M. Bredemeier, S. Ramos, C. Solórzano, A. Duarte, M. Pinheiro, B. Stadler, J. C. Macieira, R. Ranza, J. Miranda, V. Valim, G. Castro, M. Bertolo, M. D. F. Sauma, V. Fernandes, A. C. Medeiros-Ribeiro, R. Botelho, C. Brenol, H. M. Da Silveira De Carvalho, S. Studart, G. Da Rocha Castelar Pinheiro, L. Rocha, H. De Leon de Lima, I. Pereira, M. Ohira Gazzeta, A. Kakehasi, P. Louzada, A. L. S. Hayata, F. Pina, C. Lupo, L. Balarini, I. G. Silveira, S. Kowalski, D. Titton, A. Ranzolin, R. Xavier, I. Laurindo, M. Antonio Araujo Da Rocha Loures
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Golimumab and certolizumab were the last original anti-TNF agents approved in Brazil for the treatment rheumatoid arthritis (RA). Recent studies indicate that certolizumab is associated with higher risk of infections [1] and golimumab with better drug survival compared to the other anti-TNF agents [2], although they have not been compared in head-to-head trials. <h3>Objectives</h3> To evaluate the risk of adverse effects and survival of treatment course in RA patients treated with certolizumab or golimumab. <h3>Methods</h3> BiobadaBrasil is a multicentric registry-based cohort study of Brazilian patients with rheumatic diseases starting their first biologic disease modifying anti-rheumatic drug [3]. The present analysis includes RA patients recruited from Jan 2009 to Oct 2019, followed-up over one or two courses of treatment (latest date, Nov 19, 2019). A treatment course is defined as a period during which the medication scheme does not change. The primary outcome was the incidence of serious adverse events (AEs) and total AEs. System-specific AEs, treatment interruption for any reason, interruption due to AEs and due to inefficacy served as secondary outcomes. Negative binomial regression with generalized estimating equations (to calculate multivariate incidence rate ratios [mÌRRs]) and extended (frailty) Cox proportional hazards models were used for statistical analyses (both types of analyses allowing time-fixed and time-varying covariates over multiple courses of treatment). <h3>Results</h3> In total, 227 patients (120 courses, 269.1 patient-years [PY] on treatment with certolizumab and 119 courses, 287.4 PY on golimumab therapy) were enrolled. Patients' features (female: 88.3%; seropositivity: 14.6%; mean age, 52.5 years; mean disease duration, 10.1 years) were comparable between the groups, but start of treatment with certolizumab was on average one year later than golimumab. The crude incidence of serious AEs was 9.2/100PY for certolizumab and 6.6/100 PY for golimumab. The incidence of any (total) AEs was 37.1/100 PY for certolizumab and 59.8/100 PY for golimumab. The risk of serious and total AEs (primary outcomes) did not differ significantly between the study groups (Figure 1). There was also no significant difference in the risk of infections and other secondary outcomes. Persistence of treatment and reasons for interruption of therapy course also were not significantly different between certolizumab and golimumab (Table 1). <h3>Conclusion</h3> In this cohort study of Brazilian RA patients, we did not observe significant differences between certolizumab and golimumab in relation to safety outcomes and persistence of treatment course. <h3>References</h3> [1] Janke K et al. BMJ 2020;370:m2288. [2] Kondo M et al. Mod Rheumatol 2019;29:928-935. [3] Bredemeier M et al. J Rheumatol 2021;48:1519-527 <h3>Acknowledgements</h3> acknowledgements to Patricia Cabral -coordinator- and SBR. <h3>Disclosure of Interests</h3> None Declared.